Biosimilars/News
Amgen’s adalimumab biosimilar will only be launched in US in 2023
US-based biotech giant Amgen and pharma giant AbbVie announced on 28 September 2017 that they had reached a ‘global resolution’ ending all patent litigation regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab).
Bevacizumab similar biologic launched in India
India-based biologicals specialist Biocon announced on 23 November 2017 the launch of its product Krabeva, a ‘similar biologic’ of bevacizumab, in India.
FDA approves trastuzumab biosimilar Ogivri
On 1 December 2017, the US Food and Drug Administration (FDA) approved its first trastuzumab biosimilar.
EMA accepts applications for pegfilgrastim and trastuzumab biosimilars from Biocon/Mylan
India-based biologicals specialist Biocon and US-based partner Mylan announced on 1 December 2017 that the applications for approval for their proposed pegfilgrastim (MYL‑1401H) and trastuzumab (MYL‑1401O) biosimilars have been accepted by the European Medicines Agency (EMA).
EC approval for trastuzumab biosimilar Ontruzant
South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 20 November 2017 that it had received European Commission (EC) approval for its biosimilar trastuzumab product Ontruzant (SB3).
South Africa approves first non-originator biological
South Africa’s Medicines Control Council (MCC) has approved the country’s first non-originator biological, filgrastim, from Teva Pharmaceutical Industries (Teva).
EMA approval for bevacizumab biosimilar Mvasi
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 10 November 2017 that it had recommended granting marketing authorization for the bevacizumab biosimilar Mvasi.
EC approval for adalimumab biosimilar Cyltezo
Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer) announced on 13 November 2017 that it had received European Commission (EC) approval for its biosimilar adalimumab product Cyltezo (BI 695501).
Adalimumab and trastuzumab biosimilars approved in South Korea
South Korean biosimilars maker Samsung Bioepis announced on 9 November 2017 that it had received marketing approval for its biosimilar version of Roche’s blockbuster breast cancer therapy Herceptin (trastuzumab) from Korea’s Ministry of Food and Drug Safety (MFDS). The news follows another announcement by the company on 22 September 2017 that it had also gained approval for its adalimumab biosimilar (SB5).
EMA accepts biosimilar pegfilgrastim application from Sandoz
Sandoz, the generics division of Novartis, announced on 27 October 2017 that the regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the European Medicines Agency (EMA).
